Transcorneal Electrical Stimulation (TES) for the Treatment of Amblyopia

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Amblyopia

In brief

This is a prospective, randomized, parallel group sham-controlled blinded clinical trial to assess the feasibility and efficacy of transcorneal electrical stimulation (TES) in the improvement of visual function outcomes in adults with amblyopia. The trial will assess the treatment effect of TES to Sham TES in the amblyopic eye of affected patients.

Key facts

Study ID

NCT02495935

Run by

Wills Eye

People needed

40

Starts

2015-07-01

Expected to finish

2020-08-01

Last updated by the study team

2020-03-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years
• Diagnosis of amblyopia made by the principal investigators.
• Best corrected visual acuity in the amblyopic eye equal to or worse than 20/70
• Willing and able to give informed consent and to participate for the full duration of the study.
• Strabismus less than 10 prism diopters.

You may not qualify if…

• Any other significant ophthalmologic disorder or condition with relevant effect upon visual function as evaluated by principal investigator. (eg. Retinal degeneration, proliferative diabetic retinopathy, age related macular degeneration, optic nerve abnormality)
• Women who are pregnant or women with childbearing potential who are unwilling to use medically acceptable means of birth control for study duration.
• Presence of a pacemaker, any metal artifacts in head and trunk, any history of epileptic seizure or severe psychiatric disease (schizophrenia, etc.)
• Inability to detect phosphenes above 0.5mA at time of threshold detection.

Where it is running

• WillsEye Hospital — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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